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  1. Drug Development Tool Qualification Programs

List of Qualified Biomarkers

List of Qualified Biomarkers

Qualified Biomarkers and Supporting Information

Requestor Qualified Biomarker(s) Abbreviated Biomarker Description Abbreviated COU Qualification Decision Supporting Documents

Predictive Safety and Testing Consortium (PSTC), Nephrotoxicity Working Group (NWG)

Albumin, β2- Microglobulin, Clusterin, Cystatin C, KIM-1, Total Protein, and Trefoil factor-3

Urinary nephrotoxicity biomarkers as assessed by immunoassays

Safety biomarker to be used with traditional indicators to indicate renal injury in rat

Qualified
4/14/2008

4/14/2008: FDA Letter

1/16/2009: FDA Review

 

International Life Sciences Institute (ILSI)/ Health and Environmental Sciences Institute (HESI), Nephrotoxicity Working Group

Clusterin, Renal Papillary Antigen (RPA-1)

Urinary nephrotoxicity biomarkers as assessed by immunoassays

Safety biomarker to be used with traditional indicators to indicate renal injury in rat

Qualified
9/22/2010
 

Not Qualified: Alpha-s-glutathione transferase

9/22/2010: FDA Letter

9/13/2010: FDA Review

PJ O'Brien, WJ Reagan, MJ York and MC Jacobsen

Cardiac troponins T (cTnT) and I (cTnI)

Serum/plasma cardiotoxicity biomarkers as assessed by immunoassay

Safety biomarker to indicate cardiotoxicity in rats, dogs or monkeys when testing known cardiotoxic drugs and may be used to help estimate non-toxic human dose

Qualified
2/23/2012

2/23/2012: FDA Letter

1/24/2011: FDA Review

Mycoses Study Group

Galactomannan

Serum/broncho-alveolar lavage fluid biomarker: as assessed by immunoassay

Diagnostic biomarker used with other clinical and host factors to identify patients with Invasive Aspergillosis

Qualified


11/14/2015

11/14/2015:FDA Guidance

Various Dates: FDA Reviews

Chronic Obstructive Pulmonary Disease (COPD) Biomarker Qualification Consortium (CBQC)

Fibrinogen

Plasma biomarker as assessed by immunoassay

Prognostic biomarker used with other characteristics to enrich for COPD exacerbations

Qualified
9/14/2016

9/14/2016: FDA Guidance

Various Dates: FDA Reviews

Polycystic Kidney Disease Outcomes Consortium

Total Kidney Volume (TKV)

TKV as assessed by MRI, CT and US

Prognostic biomarker with patient age and baseline glomerular filtration rate for Autosomal Dominant Polycystic Kidney Disease

 

 

Qualified
9/15/2016
 

9/15/2016: FDA Guidance

Various Dates: FDA Reviews

Critical Path Institute's Predictive Safety Testing Consortium Nephrotoxicity Working Group (CPATH PSTC-NWG), and Foundation for the National Institutes of Health’s Biomarker Consortium Kidney Safety Biomarker Project Team (FNIH BC-KSP)

clusterin (CLU), Cystatin-C (CysC), Kidney Injury Molecule-1 (KIM-1), N-acetyl-beta-D-glucosaminidase (NAG), Neutrophil Gelatinase-Associated Lipocalin (NGAL), and osteopontin (OPN)

Urinary nephrotoxicity biomarker panel as assessed by immunoassays

Safety biomarker panel to aid in the detection of kidney tubular injury in phase 1 trials in healthy volunteers

7/25/2018

8/15/2018: FDA Letter

Various Dates: FDA Reviews

 
University of Washington Department of Laboratory Medicine   Plasmodium 18S rRNA/rDNA Plasmodium falciparum 18S rRNA/rDNA (copies/ml) measured in blood samples by a
nucleic acid amplification test
Monitoring biomarker informs initiation of treatment with anti-malarial drug following controlled human malaria infection (CHMI) with P. falciparum sporozoites in healthy subjects in clinical studies for vaccine and/or drug development. Qualified,
October 12, 2018
10/12/2018: FDA Letter Various Dates:
FDA Reviews

 

Additional Biomarker Information

 

Contact us at: CDER-BiomarkerQualificationProgram@fda.hhs.gov